Balanced IV Fluids for Kids with Acute Gastroenteritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study prospectively follows children aged 6 months to 5 years with acute gastroenteritis who require IV fluids. It compares early biochemical and clinical outcomes between those treated with balanced crystalloids (Isolyte-S) and those given normal saline, focusing on metabolic acidosis and bicarbonate levels. The protocol emphasizes physician-initiated fluid orders and real-world practice without research-driven assignments. The rationale is that balanced crystalloids may better correct acidosis due to lower chloride load and bicarbonate precursors. Prior evidence suggests potential benefits but with uncertain certainty, warranting additional observational data in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: 6 months to 5 years (60 months) inclusive
* Clinical diagnosis of acute gastroenteritis: acute diarrhoea (3 or more loose stools per 24 hours) with or without vomiting; symptom duration 7 days or less
* Clinician-initiated indication for intravenous rehydration
* IV fluid order placed and treatment initiated independently by the treating physician, without research team influence

Exclusion Criteria:

* Chronic systemic disease (congenital heart disease, chronic kidney disease, chronic lung disease, inborn errors of metabolism, primary immunodeficiency)
* Hypernatraemic dehydration (serum sodium \>= 150 mEq/L at baseline)
* Diabetic ketoacidosis, primary metabolic crisis, or suspected surgical abdomen
* Bloody diarrhoea or suspected invasive enteric infection requiring alternative management algorithm
* Hypoglycaemia (blood glucose \< 60 mg/dL) at presentation
* Symptom duration exceeding 7 days
* Receipt of 20 mL/kg or more of IV fluid in the 24 hours preceding enrolment

Where it's running

• Aydin Adnan Menderes University Hospital, Department of Pediatric Emergency Care
  Aydin, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Aykut Çağlar, Professor
• Email: aykutcaglar@gmail.com
• Phone: +905303337877

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.